NCT06860945 Development of a Predictive Model for Sexually Transmitted Infections in Individuals Using Pre-Exposure Prophylaxis for HIV in Spain
| NCT ID | NCT06860945 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitario de Valme |
| Condition | Sexually Transmitted Infections (STIs) |
| Study Type | OBSERVATIONAL |
| Enrollment | 9,000 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 9,000 participants in total. It began in 2025-01-01 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Objective: To develop and validate a predictive model for acquiring sexually transmitted infections (STIs) in individuals using HIV pre-exposure prophylaxis (PrEP) within the national program providing this strategy. Methods: Ambispective cohort study, multicentric (23 Spanish hospitals). All PrEP users, with follow-up within the program, will be included. Entry into the program will be considered as the baseline visit. From there, patients are followed quarterly, following the national protocols for monitoring PrEP users in Spain. At each visit, diagnosis of different STIs (serum, pharyngeal swab, urethral or urine sample, rectal swab, endocervical/vaginal swab, ulcer) is performed. Primary outcome variable: development of an STI (Yes/No). The following STIs will be considered: syphilis, Neisseria gonorrhoeae (NG) infection, Chlamydia trachomatis (CT) infection, lymphogranuloma venereum (LGV), Mycoplasma genitalium (MG) infection, genital herpes, hepatitis A, hepatitis B, hepatitis C, HIV infection, and MPOX. Secondary outcome variable: number of diagnosed STIs. In order to determine factors associated with acquiring an STI, multivariate analyses will be conducted using logistic regression. The best models will be analyzed in the validation population. To compare the models, we will follow the Bayesian approach suggested by Benavoli et al.
Eligibility Criteria
Inclusion Criteria: * All individuals with documented initiation of oral PrEP (daily or event-driven regimens), who have collected the medication at least once and have taken at least one pill, will be included in the study. The approved criteria for the use of oral PrEP in Spain, as recommended by the Spanish Gesida guidelines (GeSIDA. Recomendaciones sobre la Profilaxis Pre-Exposición para la Prevención de la Infección por VIH en España. Marzo 2023. Available at http://.gesida-seimc.org/category/guias-clinicas/otras-guias-vigentes/), are as follows: * People without HIV infection at the time of cohort inclusion * Age ≥ 16 yr who meet the following criteria: * MSM and transgender women with at least two of the following criteria during the last year: \> 10 sexual partners; Condomless anal sex; Chemsex; PEP; ≥ 1 STI * Sex worker women who report non-habitual use of condoms. * Cisgender males/females, who report condomless and present at least two of the same criteria as MSM and transgender. * PWID with unsafe injection practices Exclusion Criteria: none \-
Contact & Investigator
Anaïs Corma-Gómez, MD, PhD
PRINCIPAL INVESTIGATOR
Hospital Clínico Universitario de Valencia
Frequently Asked Questions
Who can join the NCT06860945 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Sexually Transmitted Infections (STIs). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06860945 currently recruiting?
Yes, NCT06860945 is actively recruiting participants. Contact the research team at anais.corgo@gmail.com for enrollment information.
Where is the NCT06860945 trial being conducted?
This trial is being conducted at Almería, Spain, Cadiz, Spain, Cartagena, Spain, Córdoba, Spain and 11 additional locations.
Who is sponsoring the NCT06860945 clinical trial?
NCT06860945 is sponsored by Hospital Universitario de Valme. The principal investigator is Anaïs Corma-Gómez, MD, PhD at Hospital Clínico Universitario de Valencia. The trial plans to enroll 9,000 participants.